Regulatory Affairs

3R PHARMA CONSULTING - Reducing Regulatory Risk

3R PHARMA CONSULTING provides cost-effective, timely solutions to registration filings and challenges in pharmaceutical development strategies across Europe, the US and the rest of world.

Advice on quality/CMC aspects of pharmaceutical development

3R PHARMA CONSULTING offers regulatory advice and services covering quality-related aspects of pharmaceutical development. 3R PHARMA CONSULTING strives for fast submissions and approvals of applications.

GMP audits/mock inspections

3R PHARMA CONSULTING conducts internal inspections, pre-approval mock inspections, as well as GMP Audits of API manufacturers and manufacturers of finished dosage forms.

Evaluation of stability studies

Clients are provided with scientific and technical advice, as well as stability reports and summaries which include statistical analysis of stability data.

Courses and workshops on quality aspects

3R PHARMA CONSULTING offers basic introductory courses, as well as specialised workshops and training courses, tailored to the needs of the customer. These courses can either be organised in-house or externally.

Dr. Manuel Zahn, Managing Director at 3R PHARMA CONSULTING

manuel kahn

Manuel Zahn is the founder and managing director of 3R PHARMA CONSULTING.

Dr. Zahn has more than 29 years of experience in the pharmaceutical industry (in Germany and Sweden), as well as 25 years' experience in regulatory affairs (worldwide). For more information, please click here.

Events and seminars

Successfully Handling Temperature Excursions and Using Stability Data to Support Product Shelf-Life During Transport and Shipping
Pre-Conference Workshop Tuesday 24 March 2015

Informa Annual stability Testing Conference
London 25-26 March

Evening Seminar: Ensuring Effective Change Management and Impact on Stability Programs
Wednesday 25 March 2015

Previous events and seminars

Dr. Zahn will be hosting an evening seminar on 12th February 2014 at the 'Veterinary Medicine: From Vision to Product' conference. The seminar is titled, 'Stability by Design for Veterinary Medicines'. On the final day of the three day conference, he will be delivering the following presentation, 'Practical Advice on Developing a Stability Protocol for the Global Market'.

Dr. Zahn will be making an appearance at the 'Stability Testing for Pharmaceuticals' conference in Barbican, London. On 17th March 2014, he will be participating as a speaker at the pre-conference workshop, 'Practically Managing Temperature Excursions and Using Stability Data to Support Shelf-Life during Shipping and Transport'.

This interactive workshop will provide practical advice on managing temperature excursions and effectively using stability data to support shelf-life during shipping and transport.

Dr. Zahn will be chairing the conference on the first day of the conference on 18th March 2014, where he will be delivering a presentation titled, 'Understanding and practically conducting stability studies for countries in climatic zones III, IVa and IVb'.

On the same day, he will also be contributing to the interactive round table discussion, 'Sharing experiences and challenges with conducting stability testing for the emerging markets'.

Contact details:
3R Pharma Consulting GmbH

Wildbader Str. 3
75335 Dobel
Phone: +49-(0)7083-527 6870
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